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Motor Activity and Threshold and Tolerance to Experimentally Induced Pain in Healthy Man

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Motor Activity and Threshold and Tolerance to Experimentally Induced Pain in Healthy Man Gut: first published as 10.1136/gut.25.5.513 on 1 May 1984. Downloaded from Gut, 1984, 25, 513-519 Ceruletide increases dose dependently both jejunal motor activity and threshold and tolerance to experimentally induced pain in healthy man G STACHER, H STEINRINGER, G SCHMIERER, C SCHNEIDER, S WINKLEHNER, G MITTELBACH, C DE PAOLIS, AND C PRAGA From the Psychophysiology Unit at the Psychiatric and First Surgical Clinic, University of Vienna, Vienna, Austria, and Farmitalia Carlo Erba, Milano, Italy SUMMARY The effects of ceruletide on jejunal motility and experimentally induced pain were studied in 16 healthy men, who participated each in four experiments and received in random double blind fashion 5, 10, or 20 ,g ceruletide intramuscularly or placebo. Jejunal pressures were recorded by three perfused catheters with orifices between 10 and 20 cm aboral of the ligament of Treitz. Ceruletide dose dependently diminished phase I and increased phase II type activity and tended to reduce the number, but not the duration, of activity fronts. The number and amplitude of contractions as well as the area under the curve increased significantly and dose dependently as did threshold and tolerance to electrically and threshold to thermally induced pain. Only mild sedative and other side effects occurred. Ceruletide (INN proposed by the WHO) or, as it produce a decrement in response to noxious stimula- http://gut.bmj.com/ was named formerly, caerulein is a decapeptide of tion,15 16 in man ceruletide yields prompt and the amino acid sequence Pyr-Gln-Asp-Tyr(SO3H)- complete relief of pain not only from biliary1 19 but Thr-Gly-Trp-Met-Asp-Phe-NH2 and is structurally also from renal colics,17 abolishes cancer pain, 20 and related to the cholecystokinin (CCK) - gastrin alleviates experimentally induced pain.2' 22 The family. It was isolated from the skin of the present study was performed to investigate whether Australian hylid frog Hyla caerulea by the group of synthetic ceruletide (Farmitalia Carlo Erba, Milan, Erspamer' and synthesised subsequently.2 The Italy; purity 94.8%) in doses of 5, 10, and 20 utg peptide has been reported to stimulate myoelectrical intramuscularly would exert both stimulating effects on October 1, 2021 by guest. Protected copyright. spiking as well as the contractile activity of the distal on the motor activity of the upper jejunum and duodenum and the jejunum in man3 4 and, in the analgesic effects on experimentally induced pain in rat,5 to increase the tone of all segments of the small healthy human subjects. intestine except of the duodenum, and to reduce the transit time strikingly not only in healthy subjects Methods but also in patients suffering from postoperative intestinal paralysis.6'l These actions of ceruletide SUBJECTS parallel those of its mammalian counterpart chole- Sixteen healthy men ranging in age from 20 to 32 cystokinin which has been shown to increase dose years (mean 25-4 years) were studied. Only subjects relatedly the motor activity of the jejunum 11-13 and not taking drugs at the time of the experiment, to increase jejunal but not duodenal and ileal spike having regular bowel movements, and without any activity. 14 It has been discovered recently that these history of gastrointestinal disease or previous peptides not only have potent effects on the gastro- abdominal surgery were included. They were given intestinal tract but also are endowed with analgesic a short explanation of the purpose of the research properties: in mice ceruletide and cholecystokinin and a description of the procedures to be followed. They were further given a description of any Address for correspondence: Dr G Stacher, Psychophysiologisches Labora- torium. Psychiatrische Universitatsklinik. Wahringer Gurtel 74-76. A-1090 reasonably foreseeable risks or discomforts. Written Wien, Austria. consent to participate was obtained from each Received for publication 12 August 1983 subject. Before it was initiated, the investigation 513 514 Stacher, Steinringer, Schmierer, Schneider, Winklehner, Mittelbach, De Paolis, and Praga Gut: first published as 10.1136/gut.25.5.513 on 1 May 1984. Downloaded from was approved by the Institutional Committee on on-line at 30 hertz (Hz) by means of a Hewlett- Studies Involving Human Subjects. Packard 21MX E-series computer (Hewlett-Packard Company, Palo Alto, Ca). Jejunal pressures were EXPERIMENTAL DESIGN analysed by a computer program which determined Each subject participated in four experimental for each one minute period the mean end-expiratory sessions at one week intervals. The subjects were base line pressure, the number, the amplitude, and instructed to refrain from eating after 2200 hours on the duration of contractions, as well as the area the evening preceding the experiment, and to eat enclosed by the pressure curve and the base line and drink nothing before coming to the laboratory pressure as an overall index of motility. The pattern on the experimental day. A multilumen polyvinyl of jejunal motor activity was analysed blindly by two tube with recording orifices 3 cm apart and an empty independent observers being unaware of the rubber bag attached to its tip was inserted via the treatment given. The identification of an activity nose into the stomach. The bag was then filled with front or phase III of the fasting pattern of the 2 ml of mercury to facilitate transit. The tube was migrating motor complex (MMC;21 21) was based on positioned under fluoroscopic control so that the three criteria: the appearance of an uninterrupted pressure recording orifices were located between 10 burst of pressure waves of at least three minutes and 20 cm aboral of the ligament of Treitz. After duration and produced at the slow wave frequency this procedure, the subjects reclined on a bed in a of the upper jejunum, the aboral progression of the semirecumbent supine position and remained thus front over all three recording orifices, and a period until the end of the experiment. Ten minutes after of complete quiescence following the activity front. reclining the recording started. Each experiment The recordings of motility in the remaining time comprised 10 15 minute periods. The procedure were divided into phase I, complete quiescence of at during these periods was identical: from minute 1 to least three minutes duration subsequent to an 5, threshold and tolerance to electrically induced activity front and recorded at all three catheter pain, threshold to thermally induced pain, reaction orifices, and phase II, intermittent activity. time to acoustic stimuli, and blood pressure were measured and the subjects asked to complete RespiratDry rate, heart rate, and bloodpressure self-rating scales. During minute 6 to 15, the Respiratory rate was monitored by means of a subjects were instructed to refrain from speaking Beckman strain gauge pneumograph fitted around and from all unnecessary movements. At the the subject's abdomen and a Beckman 9853A http://gut.bmj.com/ beginning of the third 15 minute period, the subjects coupler, and heart rate was processed by a Beckman received, under double blind conditions, intra- 9857 cardiotachometer coupler on the base of a muscular injections of either (1) 5 ug ceruletide, (2) chest wall electrocardiogram. Systolic and diastolic 10 ,ug ceruletide, (3) 20 ,ug ceruletide or (4) saline blood pressure were recorded by means of an placebo (0.15 M). The sequence in which they automatic device (Boso-Digimat, Bosch & Sohn, received the treatments on the different days was Jungingen, West Germany) and an inflatable cuff randomised according to a plan with four 4x4 Latin around the non-dominant arm. squares. on October 1, 2021 by guest. Protected copyright. Threshold and tolerance to electrically induced pain Measurement of jejunal motor activity Chains of square wave constant current impulses of Jejunal pressures were recorded continuously by 1 millisecond duration and a pulse frequency of 30 means of a multilumen catheter assembly and three Hz were used to induce pain.25-27 The intensity of orifices spaced at 3 cm intervals (Mui Scientific, the impulses increased, in steps of 0-05 milliampere, Mississauga, Ontario, Canada). The catheters were linearly from zero to 12-8 milliampere, the maxi- perfused with distilled water by means of a mum intensity being reached within 25-6 seconds. pressurised capillary hydraulic infusion system (Mui The stimuli were administered by means of a pair of Scientific) at 70 kilopascal (525 millimetres of silver ball electrodes attached to the earlobe of the mercury (mmHg)). Pressures were transmitted to subjects' non-dominant side. The subjects were Beckman Type 4-327C transducers (Beckman given a handle fitted with two push buttons and Instruments, Inc, Schiller Park, Ill). The compliance instructed to press the left button as soon as they of the entire recording system was such that a perceived the stimuli as painful and thereby to sudden occlusion of the perfused catheters produced indicate pain threshold, and to press the right button a pressure rise of at least 100 mmHg per second. The when they felt they could not tolerate any further output of the transducers was recorded on a increase of stimulus intensity and thereby to indicate Beckman R-411 Dynograph using Beckman 9853A pain tolerance. Pressing the second button stopped couplers. The amplified signals then were digitised the stimulation. Six chains of stimuli were pre- Jejunal and analgesic effects of ceruletide 515 Gut: first published as 10.1136/gut.25.5.513 on 1 May 1984. Downloaded from sented. The interval between the chains ranged the fixed within subjects factors 'treatment' (one to randomly from 15 to 25 seconds. four), 'day' (experimental days one to four), 'time' (periods 1-30, 31-60, 61-90, and 91-120 minutes Threshold to thermally induced pain after drug administration), as well as of the random Radiant heat of a constant intensity was used to factor 'subject' (one to 16).
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